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Quadrox-i

FDA UDI

Class I (US FDA UDI)

by Maquet Cardiopulmonary AG

Identity

Trade Name
Quadrox-i FDA UDI
Generic Name
Extracorporeal membrane oxygenator FDA UDI
Device Name
Quadrox-i Hollow Membrane Oxygenator, Adult, with VHK Reservior, unsealed, with Universal Adaptor, without Filter; vacuum-tight, non-Coated, Sterile. The QUADROX-i Adult oxygenators are blood-gas exchangers with integrated heat exchanger and optionally integrated arterial blood filter. They are used in cardiac surgery, in combination with a heart-lung machine, to oxygenate blood, remove carbon dioxide and adjust blood temperature. FDA UDI
Model / Reference
SQUADROX-i HMO 70000+ VHK7000 FDA UDI
Description
Quadrox-i Hollow Membrane Oxygenator, Adult, with VHK Reservior, unsealed, with Universal Adaptor, without Filter; vacuum-tight, non-Coated, Sterile. The QUADROX-i Adult oxygenators are blood-gas exchangers with integrated heat exchanger and optionally integrated arterial blood filter. They are used in cardiac surgery, in combination with a heart-lung machine, to oxygenate blood, remove carbon dioxide and adjust blood temperature. FDA UDI

Identifiers

Catalog Number
70106.7941 FDA UDI
Primary DI / UDI-DI
04058863017792 FDA UDI
510(k) Number
K132166 FDA UDI
FDA Product Code
GOD FDA UDI
DTP FDA UDI
DTN FDA UDI
GMDN Term
Extracorporeal membrane oxygenator FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3020 FDA UDI
870.4230 FDA UDI
870.4400 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Total Volume — 335 Milliliter FDA UDI
Weight — 2.930 Kilogram FDA UDI

Quadrox-i by Maquet Cardiopulmonary AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Maquet Cardiopulmonary AG

Sources (1)

  • FDA UDI 405a4a7a-46fb-492c-bb2a-29ed8250f487 38 fields · synced Jun 1, 2026